Quality Assurance Manager

Compensation: Base salary range $125K-$155K DOE

As a critical leader in a high-growth IVD medical device company, you will scale and manage a robust Quality Management System (QMS) compliant with ISO 13485, MDSAP, and EU MDR. This role combines hands‑on QMS ownership with the leadership and mentorship of a dedicated Quality team.

• Team Leadership: Lead, coach, and mentor direct reports to foster a culture of accountability and continuous improvement.
• QMS Ownership: Define, implement, and scale the QMS in compliance with FDA 21 CFR 820 and ISO 13485.
• Quality Events: Manage and trend deviations, nonconformances, CAPAs, and complaints; ensure effective root cause analysis.
• Audit Management: Lead internal, supplier, and external audits (ISO/FDA); drive inspection readiness and remediation.
• Compliance & Documentation: Author and maintain SOPs, oversee document/change control, and serve as the eQMS owner.
• Operational Support: Oversee supplier quality and Contract Manufacturing Organizations (CMOs).

• Education: Bachelor’s degree in science, engineering, or a related field.
• Experience: 6–9 years in Quality Systems within a regulated medical device or IVD environment.
• Leadership: Proven track record of managing and developing direct reports.
• Technical Knowledge: Deep expertise in ISO 13485, 21 CFR 820, and ISO 14971.
• Systems: Proficiency with GMP‑compliant electronic systems (eQMS).
• Travel: Ability to travel up to 20% to supplier and CMO sites.